title: Drug makers and drug regulators: too close for comfort. A study of the Canadian situation.
abstract: Canadian drug laws and regulations have been made increasingly more stringent over the past 40 years and are now considered among the strictest in the world. However, there are still major gaps in the Canadian regulatory process. These deficiencies exist primarily in the areas of the evaluation of the efficacy of 'old' (pre-1963) drugs; the reporting of adverse effects of both old and investigational new drugs; and the requirements for and monitoring of clinical drug trials. Each of these problems are discussed and where possible concrete examples are used to show how these gaps have either directly or potentially endangered the health of Canadians. It is the thesis of this paper that these deficiencies result from the close working relationship between the Health Protection Branch, which is responsible for regulating drug safety, quality and efficacy, and the Pharmaceutical Manufacturers Association of Canada, representing the multinational companies. These two groups interact primarily through an extensive system of liaison committees that allow the PMAC to participate in the early stages of drug policy formation. Other groups such as workers and consumers are excluded from such discussions. The HPB has also ceded responsibility for enforcement of regulations to the PMAC in the areas of quality control of manufacturing and pharmaceutical promotion. Restricting the interactions between HPB officials and the drug companies is not a viable option. As long as the present arrangement is in place with privately owned companies being regulated by government, a situation that is likely to prevail for the foreseeable future, then it will be necessary for the two groups to have frequent and close contacts.(ABSTRACT TRUNCATED AT 250 WORDS)
authors.forename: J
authors.initials: J
authors.lastname: Lexchin
mesh_terms: D002170:Canada; D002986:Clinical Trials as Topic; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D004341:Drug Evaluation; D004345:Drug Industry; D006077:Government Agencies; D006801:Humans; D007880:Legislation, Drug; D013678:Technology, Pharmaceutical / Q000331:legislation & jurisprudence